At a Glance
- Tasks: Lead global regulatory strategies for innovative pharmaceutical products and ensure compliance.
- Company: Join a leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Dynamic team environment with potential for career advancement.
- Why this job: Make a real impact in the pharmaceutical industry while working on exciting projects.
- Qualifications: Degree in life sciences and experience in regulatory submissions required.
The predicted salary is between 63000 - 77000 £ per year.
- Type of Role
- Contract position, Inside IR35
- Location
Hybrid, 3 days on site in Paddington, London.
- Department
- Regulatory – Chemistry Manufacturing Controls
- General Summary
The Manager, Regulatory Chemistry Manufacturing Controls will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.
This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics.
This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.
- Key Duties and Responsibilities
- Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
- Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products.
- Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
- Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
- Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
- Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.
- Knowledge and Skills
- Strong interpersonal skills to exchange complex information with others and to guide others.
- Proficiency in regulatory (SFDA, EMA, Health Canada and ICH) guidelines.
- Experience in the preparation, including writing, of CMC submissions.
- Strategic thinking and strong problem-solving skills.
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
- Strong sense of planning and prioritization, and the ability to work with all levels of management.
- Capable of strategic thinking with ability to resolve complex and ambiguous situations.
- Sound knowledge of c GMP, FDA, EMA, ICH.
Education and Experience
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.
Vertex is partnering with Talent Works to manage their international temporary job openings.
If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
- Seniority Level
- Mid-Senior level
- Employment Type
- Contract
- Job Function
- Other
- Industries
- Pharmaceutical Manufacturing
- #J-18808-Ljbffr
Manager, Regulatory CMC employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer that prioritises employee well-being and professional growth. With a flexible hybrid working model, our team enjoys a supportive work culture that fosters collaboration and innovation, while also providing ample opportunities for career advancement in the dynamic field of tax compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Regulatory CMC
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Vertex Pharmaceuticals.
We think you need these skills to ace Manager, Regulatory CMC
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Vertex Pharmaceuticals.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Vertex Pharmaceuticals. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Vertex Pharmaceuticals.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Vertex Pharmaceuticals achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
